Health Canada released two draft guidances to clarify proposed changes to the agency’s abbreviated new drug submission (ANDS) pathway for generics.
The agency proposes to update the definition of “pharmaceutical equivalent” to allow certain differences in medicinal ingredients between the generic and the reference drug—such as a salt, hydrate or solvate form.
The revised term would require a generic drug to contain the same active components in similar dosage forms as its Canadian reference product (CRP). For radiopharmaceuticals, equivalence would require identical medicinal ingredients in similar dosage forms as the CRP.
The amendment does not apply to biosimilars, which the agency said must be approved under the new drug submission (NDS) pathway.
One draft guidance explains how sponsors of generics can demonstrate safety, efficacy and quality when their product has the same therapeutically active components but differ in medicinal ingredients compared to the reference product. The second draft includes advice on identifying a drug’s medicinal ingredients. The two drafts are open for comment until June 17.